The artus SARS RG RT-PCR Kit CE is intended for in vitro diagnostic use in Europe.

Reliable quantitation of SARS coronavirus load.

Detection of the quantitation standards (SARS RG QS 1–4) on the Rotor-Gene using the artus SARS RG RT-PCR Kit. NTC: no template control.

CE-IVD-marked.

In vitro diagnostic medical device.

Performance

To ensure highest sensitivity, the artus SARS RG RT-PCR Kit has been optimized to detect low numbers of SARS coronavirus RNA. The analytical sensitivity of the artus SARS RG RT-PCR Kit is 0.5 copies/µl in the PCR on the Rotor-Gene 3000.

* Internal validation of the artus SARS RG RT-PCR Kit was performed using serum. Other sample types are not completely validated yet. Current studies refer to sputum as the most suitable sample material.

Principle

The artus SARS RG RT-PCR Kit is based on the amplification and simultaneous detection of a specific region of the SARS coronavirus genome using real-time PCR. The kit provides high levels of specificity, sensitivity, and reproducibility.

Each artus SARS RG RT-PCR Kit provides 4 quantitation standards (see figure "Reliable quantitation of SARS coronavirus load"). Use of the standards enables accurate quantitation of viral load. In addition, the kit contains a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical SARS coronavirus RT-PCR is not reduced.

* Internal validation of the artus SARS RG RT-PCR Kit was performed using serum. Other sample types are not completely validated yet. Current studies refer to sputum as the most suitable sample material.

Procedure

The artus SARS RG RT-PCR Kit provides all necessary reagents optimized for reliable SARS coronavirus RNA detection and quantitation. Simply add template RNA to the ready-to-use PCR master mix, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

The artus SARS RG RT-PCR Kit enables rapid and sensitive detection of SARS RNA from sputum, serum, bronchoalveolar lavage (BAL), nasopharyngeal wash, swabs, and lung tissue with accurate quantification. The kit is available for use on the Rotor-Gene 3000.